PT-141 (bremelanotide) in hypoactive sexual desire and erectile dysfunction: effect on the anchor… — summary of findings
Outcome-by-outcome summary with effect, certainty and the reason for each downgrade.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§4Summary of findings
§4.1Summary of findings
Table 7. Summary of findings for PT-141 (bremelanotide) in hypoactive sexual desire and erectile dysfunction: effect on….
| Outcome | Participants (studies) | Effect as reported | Certainty | Reason for downgrade |
|---|---|---|---|---|
| Female Sexual Function Index desire domainThe outcome the Institute designates as anchor for this indication. | 1,256 (2) | A statistically significant but numerically small improvement in desire and distress scores | Moderate | publication bias |
| Discontinuation for adverse eventsReported as a summary-of-findings row rather than in a tolerability annex, following a public submission. | 1,033 (2) | Reported per contributing trial; see the included-studies table | Moderate | indirectness |
| Serious adverse eventsEvent counts are low; the estimate is imprecise by construction. | 1,040 (2) | Reported per contributing trial; see the included-studies table | Low | risk of bias, publication bias |
| Any adverse eventAscertained by spontaneous report in the contributing trials. | 1,086 (1) | Reported per contributing trial; see the included-studies table | Low | risk of bias, publication bias |
| Female Sexual Distress Scale item 13A secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | 849 (1) | Reported as a secondary outcome in a subset of contributing trials | Low | risk of bias, indirectness |
| International Index of Erectile FunctionA secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | 709 (1) | Reported as a secondary outcome in a subset of contributing trials | Low | risk of bias, publication bias |
| Certainty ratings describe confidence in the effect estimate for the stated outcome. They are not recommendations and do not transfer between outcomes. | ||||
§4.2Forest plot
§4.3Certainty assessment for the anchor outcome
Table 8. Reasoning recorded against each certainty domain for the anchor outcome.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Serious | The evidence base is small, recent and wholly sponsor-generated. |
| Overall: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
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